BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1282742 · Received January 7, 2009

    Report

    Report Number
    2016493-2008-00240
    Event Type
    Other
    Date Received
    January 7, 2009
    Report Date
    December 10, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE RETURN HAS BEEN REQUESTED; CUSTOMER DOES NOT CURRENTLY HAVE A DEVICE THAT THIS HAS OCCURRED IN BUT HAS AGREED TO SET ASIDE THE NEXT ONE THAT IS OBSERVED AND NOTIFY THE MANUFACTURER. TO DATE NO SPECIFIC DEVICE HAS BEEN IDENTIFIED AS HAVING THIS PROBLEM. IF THE CUSTOMER RETURNS A DEVICE FOR INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. ALL AVAILABLE INFORMATION IS INCLUDED IN SECTIONS A AND B. THIS REPORT WAS FILED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    EXACT DATE OF EVENT IS NOT KNOWN, EXACT DEVICE USED COULD NOT BE IDENTIFIED. CUSTOMER REPORTS THAT MANY OF THE UNIT'S CHEMO INFUSIONS ARE UNDERINFUSING, AS EVIDENCED BY SIGNIFICANT VOLUMES OF FLUID REMAINING IN THE BAG AT THE EXPECTED END OF THE INFUSION. PHARMACY CANNOT ACCOUNT FOR THE EXCESS VOLUME AND THIS IS A NEW FINDING SINCE THEY SWITCHED TO THE ALARIS SYSTEM EARLIER THIS YEAR; THEY NEVER SAW THIS WHEN USING THEIR PREVIOUS TECHNOLOGY. IT IS NOT LIMITED TO ONE PARTICULAR DRUG AND THERE HAVE BEEN NO CHANGES IN PHARMACY'S FILLING PROCESS, OR IN THE BAGS OR SOLUTIONS. THE INFUSIONS ARE RUN AS A PRIMARY. TYPICALLY, PHARMACY USES A 250 ML BAG OF FLUID AND ADDS 100 ML VOLUME WITH THE CHEMO DRUG; THIS IS THEN PROGRAMMED TO RUN OVER 2 HOURS. THEY ARE SEEING 50-100 ML REMAINING AT THE END OF THE 2 HOUR PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other